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FIH Clinical Investigation of Graphene Electrodes for Brain Mapping

NCT06368310 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-25

No results posted yet for this study

Summary

The goal of this clinical investigation of a medical device is to test the safety of graphene based electrodes when used during surgery for resection of brain tumors. The main questions that it aims to answer are:

* To understand the safety of the Graphene Cortical Interface when used during brain tumor surgery (primary objective);
* To assess the quality of the brain signals recorded with the Graphene Cortical Interface, their ability to stimulate the brain, how stable their function is over the duration of an operation, and their suitability for use in the operating theatre (secondary objectives).

Participants will undergo tumor surgery as usual with the study electrodes being tested alongside a standard monitoring system. If they are awake for part of their surgery they may be asked to complete specific tasks such as naming objects from a list modified for the study, to evaluate the capability to decode brain signals (exploratory objective). They will be monitored subsequently for any complications including undergoing an additional MRI scan 6 weeks after their surgery.

Conditions

Interventions

DEVICE

INBRAIN Graphene Cortical Interface

Study device to be evaluated intra-operatively alongside standard of care neurophysiological monitoring.

Sponsors & Collaborators

  • Northern Care Alliance NHS Foundation Trust

    collaborator OTHER

  • European Commission

    collaborator OTHER

  • Inbrain Neuroelectronics

    collaborator INDUSTRY

  • University of Manchester

    lead OTHER

Principal Investigators

  • David J Coope, PhD FRCS · Northern Care Alliance NHS Foundation Trust

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-06
Primary Completion
2026-06-24
Completion
2026-06-24

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06368310 on ClinicalTrials.gov